Motorized Orthosis for Lower Limb Injury

Overseen By Kate Goworek

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kessler Foundation

Disqualifiers: Hypertension, Coronary artery disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

19 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Motorized Orthosis for lower limb injury?

Research on powered ankle-foot orthoses shows they can help people with incomplete spinal cord injuries by assisting with walking, which might suggest similar benefits for other lower limb injuries. Additionally, studies on the Intrepid Dynamic Exoskeletal Orthosis (IDEO) indicate that such devices can improve function and reduce pain in patients with severe leg injuries, suggesting potential benefits of motorized orthoses. ^{1 2 3 4 5}

Is the motorized orthosis for lower limb injury safe for humans?

Motorized orthoses, also known as powered exoskeletons, have been approved by regulatory bodies like the FDA, but there are still risks such as bone fractures and soft tissue injuries. Safety measures and training are important to minimize these risks, and more research is needed to fully understand and mitigate potential adverse events. ^{6 7 8 9 10}

How does the Motorized Orthosis treatment differ from other treatments for lower limb injury?

The Motorized Orthosis is unique because it uses a motor-driven mechanism to assist movement in paralyzed lower limb joints, providing powered motion through electric motors, which is different from traditional orthoses that rely on passive support. ^{4 11 12 13 14}

What is the purpose of this trial?

The purpose of this research study is to assess the ease, convenience, and efficacy of walking when using a motor powered ankle foot orthosis (AFO) brace, in adults who have had a lower limb injury.

Eligibility Criteria

This trial is for adults who have experienced a lower limb injury, such as a sprained ankle. The study aims to include individuals who can benefit from using an assistive walking device.

Inclusion Criteria

Be willing and able to give informed consent

I injured my leg over a year ago.

I can follow the study's procedures and instructions.

Exclusion Criteria

Have medical issues that affect the unaffected side

Have any other medical conditions that doctor or physical therapist feels would affect ability to use the device

I have joint or muscle tightness that limits my walking.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 6-week rehabilitation program using a motor powered ankle foot orthosis (AFO) brace

6 weeks

Visits before and after the intervention

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Motorized Orthosis

Trial Overview The focus of the trial is on evaluating how effective and user-friendly a motorized ankle foot orthosis (AFO) brace is in improving walking ability after sustaining a lower limb injury.

Participant Groups

Group I: Adults with lower limb injury Experimental Treatment 1 Intervention

All enrolled subjects will be asked to complete the intervention.

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

Stevens Institute of Technology

Collaborator

Trials

5

Recruited

8,700+

Findings from Research

Powered exoskeletons, like the ReWalk™, Indego™, and Ekso™, have been approved as medical devices to help individuals with gait disabilities walk upright, but the understanding of their risks and safety is still developing.

There is a significant need for standardized regulations and awareness of potential risks associated with powered exoskeletons to ensure safe and effective use, as current criteria for their use and reported adverse events vary widely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk management and regulations for lower limb medical exoskeletons: a review. He, Y., Eguren, D., Luu, TP., et al.[2020]

Two cases of bone fractures were reported during the use of powered robotic exoskeletons in patients with spinal cord injury, highlighting the potential risks associated with unexpected technical failures.

Proper alignment of the exoskeleton with the user's body is crucial to minimize fracture risks, and additional safety training is recommended for both patients and instructors to handle emergency situations effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case Report: Description of two fractures during the use of a powered exoskeleton. van Herpen, FHM., van Dijsseldonk, RB., Rijken, H., et al.[2023]

A systematic review of 50 studies involving 985 subjects revealed that adverse events (AEs) occurred in 18 studies, with over 169 device-related AEs reported, primarily soft tissue injuries and musculoskeletal issues, particularly in end-effector and exoskeleton devices.

The most common risks associated with stationary robot-assisted gait training include excessive pressure and shear at the interface between the device and the user, as well as misalignments that increase forces on the musculoskeletal system, highlighting the need for improved reporting and safety measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occurrence and Type of Adverse Events During the Use of Stationary Gait Robots-A Systematic Literature Review. Bessler, J., Prange-Lasonder, GB., Schulte, RV., et al.[2021]

Powered gait orthoses effectively induce movement in the lower limb joints of individuals with spinal cord injuries, improving walking mechanics and reducing strain on upper body muscles during ambulation.

While these devices enhance gait parameters, the impact on muscle activity remains uncertain, indicating a need for further research to optimize their design and functionality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of powered orthoses on walking in persons with paraplegia. Arazpour, M., Hutchins, SW., Ahmadi Bani, M.[2015]

References

1. England pubmed.ncbi.nlm.nih.gov

The effects of powered ankle-foot orthoses on joint kinematics and muscle activation during walking in individuals with incomplete spinal cord injury. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Outcomes Associated With the Intrepid Dynamic Exoskeletal Orthosis (IDEO): A Systematic Review of the Literature. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Intuitive control of a powered prosthetic leg during ambulation: a randomized clinical trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

New concepts in lower limb orthotics. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Microprocessor Controlled Knee Ankle Foot Orthosis (KAFO) vs Stance Control vs Locked KAFO: A Randomized Controlled Trial. [2021]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Risk management and regulations for lower limb medical exoskeletons: a review. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Case Report: Description of two fractures during the use of a powered exoskeleton. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Occurrence and Type of Adverse Events During the Use of Stationary Gait Robots-A Systematic Literature Review. [2021]

9. Germany pubmed.ncbi.nlm.nih.gov

Safe design of surgical robots - a systematic approach to comprehensive hazard identification. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Active Upper Limb Orthoses Using Brain-Machine Interfaces for Rehabilitation of Patients With Neurological Disorders: Protocol for a Systematic Review and Meta-Analysis. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Clinical application of the modified medially-mounted motor-driven hip gear joint for paraplegics. [2019]

12. France pubmed.ncbi.nlm.nih.gov

A functional comparison of conventional knee-ankle-foot orthoses and a microprocessor-controlled leg orthosis system based on biomechanical parameters. [2016]

13. France pubmed.ncbi.nlm.nih.gov

The efficacy of powered orthoses on walking in persons with paraplegia. [2015]

14. United States pubmed.ncbi.nlm.nih.gov

Below-knee orthosis: a wrap-around design for ankle-foot control. [2004]